Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124786882 | 12478688 | 2 | F | 2013 | 20160818 | 20160619 | 20160829 | EXP | US-BAXTER-2016BAX030809 | BAXTER | 0.00 | F | Y | 0.00000 | 20160829 | OT | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124786882 | 12478688 | 1 | PS | CYCLOPHOSPHAMIDE FOR INJECTION, USP | CYCLOPHOSPHAMIDE | 1 | Unknown | 4 CYCLES, NEOADJUVANT CHEMOTHERAPY | 40745 | POWDER FOR SOLUTION FOR INJECTION | /cycle | ||||||||
| 124786882 | 12478688 | 2 | SS | ADRIAMYCIN | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | 4 CYCLES, NEOADJUVANT CHEMOTHERAPY | 0 | /cycle | |||||||||
| 124786882 | 12478688 | 3 | SS | TAXOL | PACLITAXEL | 1 | Intravenous (not otherwise specified) | 1 CYCLE | 0 | /cycle | |||||||||
| 124786882 | 12478688 | 4 | SS | TAXOTERE | DOCETAXEL | 1 | Unknown | 1 CYCLE | U | 0 | /cycle | ||||||||
| 124786882 | 12478688 | 5 | SS | TAXOTERE | DOCETAXEL | 1 | Unknown | NEOADJUVANT CHEMOTHERAPY, 6 CYCLES | U | 0 | /cycle | ||||||||
| 124786882 | 12478688 | 6 | SS | CARBOPLATIN. | CARBOPLATIN | 1 | Unknown | NEOADJUVANT CHEMOTHERAPY, 6 CYCLES | 0 | /cycle | |||||||||
| 124786882 | 12478688 | 7 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Unknown | NEOADJUVANT CHEMOTHERAPY, 6 CYCLES | 0 | /cycle | |||||||||
| 124786882 | 12478688 | 8 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Unknown | 0 | /cycle | ||||||||||
| 124786882 | 12478688 | 9 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Unknown | 0 | /cycle | ||||||||||
| 124786882 | 12478688 | 10 | SS | pertuzumab | PERTUZUMAB | 1 | Unknown | NEOADJUVANT CHEMOTHERAPY, 6 CYCLES | 0 | /cycle | |||||||||
| 124786882 | 12478688 | 11 | SS | pertuzumab | PERTUZUMAB | 1 | Unknown | 0 | /cycle | ||||||||||
| 124786882 | 12478688 | 12 | SS | tamoxifen | TAMOXIFEN | 1 | Unknown | 0 | |||||||||||
| 124786882 | 12478688 | 13 | SS | ARIMIDEX | ANASTROZOLE | 1 | Unknown | 0 | |||||||||||
| 124786882 | 12478688 | 14 | SS | KADCYLA | ADO-TRASTUZUMAB EMTANSINE | 1 | Unknown | 0 | |||||||||||
| 124786882 | 12478688 | 15 | SS | FASLODEX | FULVESTRANT | 1 | Unknown | 0 | |||||||||||
| 124786882 | 12478688 | 16 | SS | XELODA | CAPECITABINE | 1 | Unknown | 0 | |||||||||||
| 124786882 | 12478688 | 17 | SS | AFINITOR | EVEROLIMUS | 1 | Unknown | 0 | |||||||||||
| 124786882 | 12478688 | 18 | SS | AFINITOR | EVEROLIMUS | 1 | Unknown | 0 | 5 | MG | |||||||||
| 124786882 | 12478688 | 19 | SS | AFINITOR | EVEROLIMUS | 1 | Unknown | INCREASED DOSE OF 5 AND 10MG ALTERNATING | 0 | ||||||||||
| 124786882 | 12478688 | 20 | SS | EXEMESTANE. | EXEMESTANE | 1 | Unknown | 0 | |||||||||||
| 124786882 | 12478688 | 21 | C | VITAMIN B COMPLEX | CYANOCOBALAMINDEXPANTHENOLNIACINAMIDEPYRIDOXINE HYDROCHLORIDERIBOFLAVIN 5'-PHOSPHATE SODIUMTHIAMINE HYDROCHLORIDEVITAMIN B COMPLEX | 1 | Unknown | 0 | |||||||||||
| 124786882 | 12478688 | 22 | C | Calcium 600+D3 | CALCIUM CARBONATEVITAMIN D | 1 | Unknown | 0 | |||||||||||
| 124786882 | 12478688 | 23 | C | multivitamin | VITAMINS | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124786882 | 12478688 | 1 | Breast cancer metastatic |
| 124786882 | 12478688 | 2 | Breast cancer metastatic |
| 124786882 | 12478688 | 3 | Breast cancer metastatic |
| 124786882 | 12478688 | 4 | Breast cancer metastatic |
| 124786882 | 12478688 | 5 | Breast cancer recurrent |
| 124786882 | 12478688 | 6 | Breast cancer recurrent |
| 124786882 | 12478688 | 7 | Breast cancer recurrent |
| 124786882 | 12478688 | 8 | Disease progression |
| 124786882 | 12478688 | 10 | Breast cancer recurrent |
| 124786882 | 12478688 | 12 | Breast cancer recurrent |
| 124786882 | 12478688 | 13 | Disease progression |
| 124786882 | 12478688 | 14 | Disease progression |
| 124786882 | 12478688 | 15 | Disease progression |
| 124786882 | 12478688 | 16 | Disease progression |
| 124786882 | 12478688 | 17 | Disease progression |
| 124786882 | 12478688 | 20 | Disease progression |
| 124786882 | 12478688 | 21 | Product used for unknown indication |
| 124786882 | 12478688 | 22 | Product used for unknown indication |
| 124786882 | 12478688 | 23 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124786882 | 12478688 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124786882 | 12478688 | Anal incontinence | |
| 124786882 | 12478688 | Breast cancer recurrent | |
| 124786882 | 12478688 | Diarrhoea | |
| 124786882 | 12478688 | Disease progression | |
| 124786882 | 12478688 | Drug ineffective | |
| 124786882 | 12478688 | Fatigue | |
| 124786882 | 12478688 | Hypoaesthesia oral | |
| 124786882 | 12478688 | Neuropathy peripheral |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 124786882 | 12478688 | 1 | 20111108 | 201201 | 0 | |
| 124786882 | 12478688 | 2 | 20111108 | 201201 | 0 | |
| 124786882 | 12478688 | 3 | 20120208 | 20120208 | 0 | |
| 124786882 | 12478688 | 8 | 20131228 | 0 | ||
| 124786882 | 12478688 | 11 | 20140116 | 0 | ||
| 124786882 | 12478688 | 12 | 20131210 | 20140520 | 0 | |
| 124786882 | 12478688 | 13 | 20140520 | 0 | ||
| 124786882 | 12478688 | 14 | 20140520 | 0 | ||
| 124786882 | 12478688 | 16 | 201602 | 0 | ||
| 124786882 | 12478688 | 17 | 201602 | 0 | ||
| 124786882 | 12478688 | 20 | 201602 | 0 |